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Internal consistency reliability is a poor predictor of responsiveness
Milo A Puhan, Dianne Bryant, Gordon H Guyatt, Diane Heels-Ansdell, Holger J Schünemann
Health and Quality of Life Outcomes , 2005, DOI: 10.1186/1477-7525-3-33
Abstract: 516 patients with chronic obstructive pulmonary disease or knee injury participating in four longitudinal studies completed generic and disease-specific HRQL questionnaires before and after an intervention that impacted on HRQL. We used Pearson correlation coefficients and linear regression to assess the relationship between internal consistency reliability (expressed as Cronbach's alpha), instrument type (generic and disease-specific) and responsiveness (expressed as the standardised response mean, SRM).Mean Cronbach's alpha was 0.83 (SD 0.08) and mean SRM was 0.59 (SD 0.33). The correlation between Cronbach's alpha and SRMs was 0.10 (95% CI -0.12 to 0.32) across all studies. Cronbach's alpha alone did not explain variability in SRMs (p = 0.59, r2 = 0.01) whereas the type of instrument was a strong predictor of the SRM (p = 0.012, r2 = 0.37). In multivariable models applied to individual studies Cronbach's alpha consistently failed to predict SRMs (regression coefficients between -0.45 and 1.58, p-values between 0.15 and 0.98) whereas the type of instrument did predict SRMs (regression coefficients between -0.25 to -0.59, p-values between <0.01 and 0.05).Investigators must look to data other than internal consistency reliability to select a responsive instrument for use as an outcome in clinical trials.Health-related quality of life (HRQL) instruments should demonstrate adequate test-retest reliability, cross-sectional and longitudinal validity before investigators use them to assess outcomes in research studies. Whether responsiveness, the ability of an instrument to detect change in HRQL when change occurs, is a measurement property distinct from reliability and validity remains, however, controversial [1-4].Lindeboom et al. purportedly tested the assumption that responsiveness is not a distinct measurement property, but is embodied in internal consistency reliability [5]. To investigate their hypothesis, the authors removed the item contributing most to internal
Elevated troponin and myocardial infarction in the intensive care unit: a prospective study
Wendy Lim, Ismael Qushmaq, Deborah J Cook, Mark A Crowther, Diane Heels-Ansdell, PJ Devereaux, the Troponin T Trials Group
Critical Care , 2005, DOI: 10.1186/cc3816
Abstract: In this 2-month single centre prospective cohort study, all consecutive patients admitted to our medical-surgical ICU were classified in duplicate by two investigators as having MI or no MI based on troponin, ECGs and echocardiograms obtained during the ICU stay. The diagnosis of MI was based on an adaptation of the joint European Society of Cardiology/American College of Cardiology definition: a typical rise or fall of an elevated troponin measurement, in addition to ischemic symptoms, ischemic ECG changes, a coronary artery intervention, or a new cardiac wall motion abnormality.We screened 117 ICU admissions and enrolled 115 predominantly medical patients. Of these, 93 (80.9%) had at least one ECG and one troponin; 44 of these 93 (47.3%) had at least one elevated troponin and 24 (25.8%) had an MI. Patients with MI had significantly higher mortality in the ICU (37.5% versus 17.6%; P = 0.050) and hospital (50.0% versus 22.0%; P = 0.010) than those without MI. After adjusting for Acute Physiology and Chronic Health Evaluation II score and need for inotropes or vasopressors, MI was an independent predictor of hospital mortality (odds ratio 3.22, 95% confidence interval 1.04–9.96). The presence of an elevated troponin (among those patients in whom troponin was measured) was not independently predictive of ICU or hospital mortality.In this study, 47% of critically ill patients had an elevated troponin but only 26% of these met criteria for MI. An elevated troponin without ischemic ECG changes was not associated with adverse outcomes; however, MI in the ICU setting was an independent predictor of hospital mortality.Cardiac troponin is specific to the myocardium, and levels in the serum rise 3–4 hours after the occurrence of cardiac symptoms in patients with acute myocardial infarction (MI) [1]. Because of its high sensitivity and specificity, elevated levels of troponin indicate myocardial damage but not the mechanism of damage. The diagnosis of MI has thus evolved follo
Association of Psychotherapy with Disability Benefit Claim Closure among Patients Disabled Due to Depression
Shanil Ebrahim, Gordon H. Guyatt, Stephen D. Walter, Diane Heels-Ansdell, Marg Bellman, Steven E. Hanna, Irene Patelis-Siotis, Jason W. Busse
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0067162
Abstract: Background Depression is the most frequent reason for receiving disability benefits in North America, and treatment with psychotherapy is often funded by private insurers. No studies have explored the association between the provision of psychotherapy for depression and time to claim closure. Methods Using administrative data from a Canadian disability insurer, we evaluated the association between the provision of psychotherapy and short-term disability (STD) and long-term disability (LTD) claim closure by performing Cox proportional hazards regression. Results We analyzed 10,508 STD and 10,338 LTD claims for depression. In our adjusted analyses, receipt of psychotherapy was associated with longer time to STD closure (HR [99% CI] = 0.81 [0.68 to 0.97]) and faster LTD claim closure (1.42 [1.33 to 1.52]). In both STD and LTD, older age (0.90 [0.88 to 0.92] and 0.83 [0.80 to 0.85]), per decade), a primary diagnosis of recurrent depression versus non-recurrent major depression (0.78 [0.69 to 0.87] and 0.80 [0.72 to 0.89]), a psychological secondary diagnosis (0.90 [0.84 to 0.97] and 0.66 [0.61 to 0.71]), or a non-psychological secondary diagnosis (0.81 [0.73 to 0.90] and 0.77 [0.71 to 0.83]) versus no secondary diagnosis, and an administrative services only policy ([0.94 [0.88 to 1.00] and 0.87 [0.75 to 0.996]) or refund policy (0.86 [0.80 to 0.92] and 0.73 [0.68 to 0.78]) compared to non-refund policy claims were independently associated with longer time to STD claim closure. Conclusions We found, paradoxically, that receipt of psychotherapy was independently associated with longer time to STD claim closure and faster LTD claim closure in patients with depression. We also found multiple factors that were predictive of time to both STD and LTD claim closure. Our study has limitations, and well-designed prospective studies are needed to establish the effect of psychotherapy on disabling depression.
The impact of illness in patients with moderate to severe gastro-esophageal reflux disease
Samer El-Dika, Gordon H Guyatt, David Armstrong, Alessio Degl'innocenti, Ingela Wiklund, Carlo A Fallone, Lisa Tanser, Sander van Zanten, Diane Heels-Ansdell, Peter Wahlqvist, Naoki Chiba, Alan N Barkun, Peggy Austin, Holger J Schünemann
BMC Gastroenterology , 2005, DOI: 10.1186/1471-230x-5-23
Abstract: We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7) across 17 Canadian centers. Patients completed three utility instruments – the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3) – and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks.The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired.GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL.The global prevalence of gastro-esophageal reflux disease (GERD), defined as heartburn once daily, is estimated to range from 5 to 7% but varies widely and depends on the definition used [1]. For example, 25% of the adult population in Belgium [2], nearly 18% in Australia [3], 20% in the United States and 9 % in Canada reported GERD symptoms once a week or more [4,5]. While heartburn is the leading symptom in GERD, the disease is associated with a broad range of esophageal problems, including acid regurgitation, epigastric pain, esophageal erosions and complications such as Barrett's esophagus, esophageal adenocarcinoma and esophageal stricture. GERD is also associated with a variety of extra-esophageal problems, including sleep disturbances, noncardiac chest pain, asthma, chronic cough and hoarseness [6].Clinicians and health services researchers are becoming mor
The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole
Alessio Degl' Innocenti, Gordon H Guyatt, Ingela Wiklund, Diane Heels-Ansdell, David Armstrong, Carlo A Fallone, Lisa Tanser, Sander van Zanten, Samer El-Dika, Naoki Chiba, Alan N Barkun, Peggy Austin, Holger J Schünemann
Health and Quality of Life Outcomes , 2005, DOI: 10.1186/1477-7525-3-4
Abstract: Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.The inclusion of patients' opinions in the assessment of interventions has gained greater prominence over the last decades. Regulator agencies now call for the inclusion of patient-reported outcomes (PRO) in clinical trials evaluating pharmaceuticals interventions [1-4]. PRO of interest include health-related quality of life (HRQL), symptom assessment, and more recently, treatment satisfaction, in gastroesophageal reflux disease (GERD).Whereas HRQL measures the patient's physical, psychological, and social level of function, treatment satisfaction assesses the patient's attitude towards the treatment, or the extent to which the patient is satisfied or not with the results of the treatment. Thus, treatment satisfaction focuses on the interaction of expectations and preferences for treatments and is defined as the individual's rating of important attributes of the process and outcomes of the treatment experience [5]. Coyne and co-workers [6] have summarized a number of patient important domai
Venous thromboembolism and bleeding in critically ill patients with severe renal insufficiency receiving dalteparin thromboprophylaxis: prevalence, incidence and risk factors
Deborah Cook, James Douketis, Maureen Meade, Gordon Guyatt, Nicole Zytaruk, John Granton, Yoanna Skrobik, Martin Albert, Robert Fowler, Paul Hebert, Guiseppe Pagliarello, Jan Friedrich, Andreas Freitag, Tim Karachi, Christian Rabbat, Diane Heels-Ansdell, William Geerts, Mark Crowther, the Canadian Critical Care Trials Group
Critical Care , 2008, DOI: 10.1186/cc6810
Abstract: In a multicenter, open-label, prospective cohort study of critically ill patients with severe acute or chronic renal insufficiency or dialysis receiving subcutaneous dalteparin 5,000 IU once daily, we estimated the prevalence of proximal DVT by screening compression venous ultrasound of the lower limbs within 48 hours of ICU admission. DVT incidence was assessed on twice-weekly ultrasound testing. We estimated the incidence of major and minor bleeding by daily clinical assessments. We used Cox proportional hazards regression to identify independent predictors of both DVT and major bleeding.Of 156 patients with a mean (standard deviation) creatinine clearance of 18.9 (6.5) ml/min, 18 had DVT or pulmonary embolism within 48 hours of ICU admission, died or were discharged before ultrasound testing – leaving 138 evaluable patients who received at least one dose of dalteparin. The median duration of dalteparin administration was 7 days (interquartile range, 4 to 12 days). DVT developed in seven patients (5.1%; 95% confidence interval, 2.5 to 10.1). The only independent risk factor for DVT was an elevated baseline Acute Physiology and Chronic Health Evaluation II score (hazard ratio for 10-point increase, 2.25; 95% confidence interval, 1.03 to 4.91). Major bleeding developed in 10 patients (7.2%; 95% confidence interval, 4.0 to 12.8), all with trough anti-activated factor X levels ≤ 0.18 IU/ml. Independent risk factors for major bleeding were aspirin use (hazard ratio, 6.30; 95% confidence interval, 1.35 to 29.4) and a high International Normalized Ratio (hazard ratio for 0.5-unit increase, 1.68; 95% confidence interval, 1.07 to 2.66).In ICU patients with renal insufficiency, the incidence of DVT and major bleeding are considerable but appear related to patient comorbidities rather than to an inadequate or excessive anticoagulant from thromboprophylaxis with dalteparin.Number NCT00138099.Approximately 30% of critically ill patients admitted to an intensive care unit (ICU)
Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials
Xin Sun, Matthias Briel, Jason W Busse, Elie A Akl, John J You, Filip Mejza, Malgorzata Bala, Natalia Diaz-Granados, Dirk Bassler, Dominik Mertz, Sadeesh K Srinathan, Per Vandvik, German Malaga, Mohamed Alshurafa, Philipp Dahm, Pablo Alonso-Coello, Diane M Heels-Ansdell, Neera Bhatnagar, Bradley C Johnston, Li Wang, Stephen D Walter, Douglas G Altman, Gordon H Guyatt
Trials , 2009, DOI: 10.1186/1745-6215-10-101
Abstract: We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes.A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize the conduct and reporting of subgroup analyses, and claim and interpretation of subgroup effects in randomized trials.The effects of healthcare interventions on the entire study population are of primary interest in clinical trials. It remains appealing, however, for investigators and clinicians to identify differential effects in subgroups based on characteristics of patients or interventions. This analytic approach, termed subgroup analysis, can sometimes be informative - but it is often misleading [1-4].Investigators frequently conduct subgroup analyses exploring multiple hypotheses [5]. Conducting multiple tests is associated with the risk of false positive results due to the play of chance [3]. This risk is particularly great if subgroup analyses are data driven: that is, when investigators perform numerous post hoc subgroup analyses seeking statistical significanc
Effectiveness of Cognitive Behavioral Therapy for Depression in Patients Receiving Disability Benefits: A Systematic Review and Individual Patient Data Meta-Analysis
Shanil Ebrahim, Luis Montoya, Wanda Truong, Sandy Hsu, Mostafa Kamal el Din, Alonso Carrasco-Labra, Jason W. Busse, Stephen D. Walter, Diane Heels-Ansdell, Rachel Couban, Irene Patelis-Siotis, Marg Bellman, L. Esther de Graaf, David J. A. Dozois, Peter J. Bieling, Gordon H. Guyatt
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0050202
Abstract: Objectives To systematically summarize the randomized trial evidence regarding the relative effectiveness of cognitive behavioural therapy (CBT) in patients with depression in receipt of disability benefits in comparison to those not receiving disability benefits. Data Sources All relevant RCTs from a database of randomized controlled and comparative studies examining the effects of psychotherapy for adult depression (http://www.evidencebasedpsychotherapies.?org), electronic databases (MEDLINE, EMBASE, PSYCINFO, AMED, CINAHL and CENTRAL) to June 2011, and bibliographies of all relevant articles. Study Eligibility Criteria, Participants and Intervention Adult patients with major depression, randomly assigned to CBT versus minimal/no treatment or care-as-usual. Study Appraisal and Synthesis Methods Three teams of reviewers, independently and in duplicate, completed title and abstract screening, full text review and data extraction. We performed an individual patient data meta-analysis to summarize data. Results Of 92 eligible trials, 70 provided author contact information; of these 56 (80%) were successfully contacted to establish if they captured receipt of benefits as a baseline characteristic; 8 recorded benefit status, and 3 enrolled some patients in receipt of benefits, of which 2 provided individual patient data. Including both patients receiving and not receiving disability benefits, 2 trials (227 patients) suggested a possible reduction in depression with CBT, as measured by the Beck Depression Inventory, mean difference [MD] (95% confidence interval [CI]) = ?2.61 (?5.28, 0.07), p = 0.06; minimally important difference of 5. The effect appeared larger, though not significantly, in those in receipt of benefits (34 patients) versus not receiving benefits (193 patients); MD (95% CI) = ?4.46 (?12.21, 3.30), p = 0.26. Conclusions Our data does not support the hypothesis that CBT has smaller effects in depressed patients receiving disability benefits versus other patients. Given that the confidence interval is wide, a decreased effect is still possible, though if the difference exists, it is likely to be small.
Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences
Deborah Cook, Ellen McDonald, Orla Smith, Nicole Zytaruk, Diane Heels-Ansdell, Irene Watpool, Tracy McArdle, Andrea Matte, France Clarke, Shirley Vallance, Simon Finfer, Pauline Galt, Tim Crozier, Rob Fowler, Yaseen Arabi, Clive Woolfe, Neil Orford, Richard Hall, Neill KJ Adhikari, Marie-Clauide Ferland, John Marshall, Maureen Meade, The PROTECT Research Coordinators, PROTECT Investigators, Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group
Critical Care , 2013, DOI: 10.1186/cc11917
Abstract: In an observational analysis of an international thromboprophylaxis trial in 67 ICUs, we examined the co-enrollment of critically ill medical-surgical patients into more than one study, and examined the clinical and trial outcomes among co-enrolled and non-co-enrolled patients.Among 3,746 patients enrolled in PROTECT (Prophylaxis for ThromboEmbolism in Critical Care Trial), 713 (19.0%) were co-enrolled in at least one other study (53.6% in a randomized trial, 37.0% in an observational study and 9.4% in both). Six factors independently associated with co-enrollment (all P < 0.001) were illness severity (odds ratio (OR) 1.35, 95% confidence interval (CI) 1.19 to 1.53 for each 10-point Acute Physiology and Chronic Health Evaluation (APACHE) II score increase), substitute decision-makers providing consent, rather than patients (OR 3.31, 2.03 to 5.41), experience of persons inviting consent (OR 2.67, 1.74 to 4.11 for persons with > 10 years' experience compared to persons with none), center size (all ORs > 10 for ICUs with > 15 beds), affiliation with trials groups (OR 5.59, 3.49 to 8.95), and main trial rather than pilot phase (all ORs > 8 for recruitment year beyond the pilot). Co-enrollment did not influence clinical or trial outcomes or risk of adverse events.Co-enrollment was strongly associated with features of the patients, research personnel, setting and study. Co-enrollment had no impact on trial results, and appeared safe, acceptable and feasible. Transparent reporting, scholarly discourse, ethical analysis and further research are needed on the complex topic of co-enrollment during critical illness.Clinical trials are essential to improve care and reduce morbidity and mortality in the intensive care unit (ICU). Some critically ill patients are eligible for more than one study. Restricting enrollment to only one study when patients are eligible for more than one is a potentially modifiable barrier to recruitment [1]. Testing two interventions concurrently can b
Pulmonary embolism in medical-surgical ICU patients
D Heels-Ansdell, N Zytaruk, M Meade, S Mehta, R Hall, R Zarychanski, M Rocha, W Lim, F Lamontagne, L McIntyre, P Dodek, S Vallance, A Davies, DJ Cooper, DJ Cook
Critical Care , 2011, DOI: 10.1186/cc9439
Abstract: Research coordinators documented all clinical, laboratory, radiologic and autopsy criteria relevant to PE, which was a secondary outcome for this multicenter trial. Patients with a possible PE were adjudicated in quadruplicate; those considered possible, probable or definite PE were considered in this analysis. PEs were considered clinically suspected if the ICU team conducted tests seeking a diagnosis; otherwise, they were incidental.In 3,659 patients, PE was clinically suspected in most patients who were diagnosed with a prevalent PE at ICU admission (12/14, 85.7%) or incident over the course of the ICU stay (57/64, 89.1%). Among 64 patients who developed a PE, only three (4.7%) had prehospital DVT or PE. Within the index hospitalization, before or after the PE diagnosis, additional acute deep venous thromboses occurred at any site in 27 (42.2%) patients with PE. Patients without PE compared with those with PE appear to have a shorter duration of ventilation (median, interquartile range) (5 (2, 11) days vs. 12 days (5.5, 20.5), P < 0.001), duration of ICU stay (9 (6, 16) days vs. 20.5 (13, 35), P < 0.001), and hospital stay (21 (13, 40) days vs. 35 (21.5, 58.5), P < 0.001), and a lower ICU mortality (15.2% vs. 31.8%, P = 0.005) and hospital mortality (22.8% vs. 31.3%, P = 0.13).The majority of PEs in these medical-surgical ICU patients were clinically suspected rather than incidental findings. More than one-half of the PEs developed in the absence of leg or other venous thromboses; in some cases, additional venous thromboses post-dated rather than pre-dated the PE. PE was associated with significantly increased morbidity and mortality in this ICU population.For the PROTECT Investigators, CCCTG and ANZICS-CTG.
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